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United States Patent |
6,089,864
|
Buckner
,   et al.
|
July 18, 2000
|
Bio-feedback, data acquisition teeth guards, methods of their
manufacture and use
Abstract
A diagnostic and therapeutic apparatus for use in the evaluation,
detection, and treatment of humans that suffer from chronic grinding of
the teeth known as "bruxing." The apparatus includes a pressure sensor
contained in a mouth piece and electronic for detecting activation of the
sensor due to bruxing and for generating an human cognizable output in
response to bruxing. The apparatus can also include electronics for
storing and analyzing human bruxing activities.
Inventors:
|
Buckner; Randall R. (Houston, TX);
Dees; John D. (Houston, TX);
Hintermister; William L. (2330 Montgomery Park Blvd. #1035, Conroe, TX 77304)
|
Assignee:
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Hintermister; William L. (Southport, NC)
|
Appl. No.:
|
243340 |
Filed:
|
February 1, 1999 |
Current U.S. Class: |
433/71; 433/6; 433/68 |
Intern'l Class: |
A61C 009/00 |
Field of Search: |
433/6,24,68,71
128/776,777
|
References Cited
U.S. Patent Documents
3349489 | Oct., 1967 | Shackelford | 433/68.
|
3390459 | Jul., 1968 | Seidenberg | 433/69.
|
4592727 | Jun., 1986 | Bloomfield | 433/71.
|
4976618 | Dec., 1990 | Anderson | 433/72.
|
5078153 | Jan., 1992 | Nordlander et al. | 433/215.
|
5458487 | Oct., 1995 | Komatsu et al. | 433/71.
|
Primary Examiner: Lucchesi; Nicholas D.
Attorney, Agent or Firm: Strozier; Robert W.
Parent Case Text
RELATED PATENT APPLICATIONS
This application is a continuation-in-part of U.S. patent application Ser.
No. 08/970,365, filed on Nov. 14, 1997 now abandoned, which claims
priority of U.S. provisional patent application Ser. No. 60/030,977 filed
on Nov. 15, 1996.
Claims
We claim:
1. An apparatus to sense teeth grinding comprising:
a. a mouth piece suitable to detachably engage teeth and a pallette of an
upper jaw including:
i. a socket designed to cover at least one tooth of the upper jaw;
ii. a pressure sensor associated with the sockets, where the sensor
produces a sensor signal when an activating pressure greater than a sensor
threshold pressure is applied thereto;
iii. a transmitter unit in electrical communication with the sensor
designed to generate an action signal when a sensor signal having an
amplitude greater than a sensor signal threshold amplitude is detected;
and
b. a receiver unit designed to receive the action signal and generate an
human cognizable output.
2. The apparatus of claim 1, wherein the transmitter unit includes:
a. a monitor designed to detect the sensor signal and to determine whether
the amplitude of the sensor signal is greater than the threshold
amplitude; and
b. a transmitter designed to transmit the action signal.
3. The apparatus of claim 1, wherein the receiver unit includes:
i. a receiver designed to receive the action signal; and
ii. an output generator designed to generate an human cognizable output in
response to the action signal.
4. The device of claim 3, wherein the receiver unit is part of the mouth
piece.
5. The apparatus of claim 1, wherein the output is a vibratory output, an
audible output, an electric output, a smell, a taste or a combination
thereof.
6. An apparatus for protecting teeth comprising:
a. a member suitable to detachably engage teeth and a pallette of an upper
jaw including:
i. a socket designed to receive the teeth of the upper jaw; and
ii. a pressure sensor associated with a plurality of molar sockets, where
each senor produces a sensor signal when an activating pressure greater
than its sensor threshold pressure is applied thereto.
7. The apparatus of claim 6, further comprising:
iii. a transmitter unit in electrical cmmunication with the sensor adapted
to produce an action signal when an amplitude of the sensor signal is
greater than a threshold sensor signal amplitude.
8. The apparatus of claim 7, wherein the transmitter unit includes:
a) a monitor designed to detect the sensor signal and to determine whether
the amplitude of the sensor signal is greater than the threshold
amplitude; and
b) a transmitter designed to generate the action signal.
9. The apparatus of claim 6, wherein further comprising:
iv. an output generator designed to generate an human cognizable output in
response to the action signal.
10. The apparatus of claim 6, wherein the output is a vibratory output, an
audible output, an electric output, a smell, a taste or a combination
thereof.
11. A method comprising the steps of:
a. placing a mouth piece apparatus designed to detachably engage teeth and
a pallette of an upper jaw in a wearer's mouth comprising:
i. sockets designed to receive the teeth of the upper jaw;
ii. a sensor associated with each socket, where the sensor produces a
sensor signal when an activating pressure greater than a sensor threshold
pressure is applied thereto;
iii. a transmitter in electrical communication with the sensors designed to
generate an action signal when a sensor signal having an amplitude greater
than a sensor signal threshold amplitude is detected; and
b. generating an human cognizable response to the action signal.
12. The method of claim 11, further comprising the step of:
c. continuing the response until the action signal stops.
13. The method of claim 11, further comprising the step of:
d. discontinuing the response when the action signal stops.
14. The method of claim 11, wherein the action signal is a start signal and
the method further comprising:
e. discontinuing the response when the action signal is a stop signal.
15. The method of claim 11, wherein the mouth piece apparatus further
includes:
iv. a receiver unit designed to receive the action signal and generate an
human cognizable output in response thereto.
16. A method comprising the steps of:
a. placing a mouth piece apparatus designed to detachably engage teeth and
a pallette of an upper jaw of a wearer's mouth comprising:
i. sockets designed to receive the teeth of the upper jaw;
ii. a sensor associated with each socket, where the sensor produces a
sensor signal when an activating pressure greater than a sensor threshold
pressure is applied thereto;
iii. a transmitter in electrical communication with the sensors designed to
generate an action signal when a sensor signal having an amplitude greater
than a sensor signal threshold amplitude is detected;
b. receiving the action signal from the mouth piece; and
c. storing information contained in the action signal.
17. The method of claim 16, further comprising the step of:
d. analyzing the information stored in step (c).
18. The method of claim 17, further comprising the step of:
e. generating an human cognizable response to the action signal.
19. The method of claim 18, wherein the information further includes a
magnitude of a force or pressure associated with each grinding episode.
20. The method of claim 16, wherein the information includes a start, a
stop and a duration of each grinding episode.
21. The method of claim 20, wherein the information further includes a
direction of the force or pressure associated with each grinding episode.
22. A mouth guard comprising:
a. a tooth portion designed to detachably engage teeth of the upper jaw
including:
i. sockets designed to receive each tooth of the upper jaw;
ii. a pressure sensing membrane associated with at least each molar socket,
where the membrane comprises a top conductive layer, a middle perforated
layer and a bottom conductive layer, where the membrane has a rest state
and an action state where the action state occurs when the top conductive
layer is brought into electrical contact with the bottom conductive layer
by the action of a pressure exerted between teeth on the upper jaw and
teeth on a lower jaw greater than a membrane threshold pressure; and
b. a pallette portion designed to detachably engage a pallette of the upper
jaw including:
i. a transmitter unit located in a central region of the pallette in
electrical communication with the membrane, where the unit generates an
action signal when the sensor signal has an amplitude greater than a
sensor signal threshold amplitude.
23. The guard of claim 22, wherein the transmitter unit includes a
transmitter for transmitting the action signal and a battery for supplying
power to the guard.
24. The guard of claim 22, wherein the transmitter unit is field activated
and includes a transmitter for transmitting the action signal and an
antenna for absorbing power from a field to power the guard.
25. An apparatus for sensing teeth grinding comprising:
a. a mouth guard comprising:
i. a tooth portion designed to detachably engage teeth of the upper jaw
including:
a) sockets designed to receive each tooth of the upper jaw;
b) a pressure sensing membrane associated with at least each molar socket,
where the membrane comprises a top conductive layer, a middle perforated
layer and a bottom conductive layer, where the membrane has a rest state
and an action state where the action state occurs when the top conductive
layer is brought into electrical contact with the bottom conductive layer
by the action of a pressure exerted between teeth on the upper jaw and
teeth on a lower jaw greater than a membrane threshold pressure;
ii. a pallette portion designed to detachably engage a pallette of the
upper jaw including:
a) a transmitter unit located in a central region of the pallette in
electrical communication with the membrane, where the unit generates an
action signal when the sensor signal has an amplitude greater than a
sensor signal threshold amplitude; and
b. a receiver unit designed to receive the action signal and generate an
human cognizable output.
26. The apparatus of claim 25, wherein the transmitter unit includes a
transmitter for transmitting the action signal and a battery for supply
power to the guard.
27. The apparatus of claim 25, wherein the transmitter unit is field
activated and includes a transmitter for transmitting the action signal
and an antenna for absorbing power from a field to power the guard.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to devices to be worn to prevent teeth
and/or jaw damage caused by "grinding of the teeth" sometimes also known
as bruxing, TMJ, clinching, gritting, or other related psychological and
physiological conditions and to methods for behavior modification of such
condition and to methods for acquiring data associated with such
conditions.
More particularly, this invention relates to mouth pieces or teeth guards
to prevent grinding of teeth and to provide bio-feed back and data
acquisition capabilities by incorporating in teeth contacting regions of
the guard, pressure sensing devices in electrical communication with an
integrated circuit device capable of monitoring the sensing devices and
transmitting a signal when a change in a normal pressure state of the
pressure devices occurs to a receiving device capable of invoking a human
cognizable response designed to indicate to the wearer when teeth grinding
is occurring and/or to collect, store and/or analyze data associated with
grinding episodes.
2. Background Information and Description of the Related Art
In prior art, the only tool that a dental doctor has now available for
handling patients that grind their teeth during sleep is a simple device
known as a mouth piece, split, teeth guard or mouth guard that is molded
out of a hard or soft polymer conforming to a patients upper palate and
teeth or lower jaw and teeth. This device offers no ability to do
diagnosis or therapy towards a cure. It's only function is to protect a
sufferer from damaging the enamel that will eventually deteriorate from
the hard pressure and friction occurring during bouts of tooth grinding.
Thus, there is a need in the art for a device that not only protects the
teeth or the enamel of the teeth and/or jaw from damage during bruxing
episodes, but also provides information that can be used either to study
teeth grinding or augment a patient's behavior to reduce and/or eliminate
bruxing episodes.
SUMMARY OF THE INVENTION
The present invention provides mouth piece or teeth guard devices that
include a flexurally resilient mouth member designed to detachably engage
a portion of or all of the teeth of a wearer's upper or lower jaw to
prevent tooth damage during teeth grinding episodes. The mouth member
includes at least one pressure sensing device incorporated into at least
one tooth socket or region thereof. The region is selected so that the
pressure sensors become interposed between teeth during grinding episodes.
The sensors are in electrical communication with electronic devices
capable of monitoring and generating an action signal in response to a
change in a state of the pressure sensing devices which signifies a teeth
grinding episode and optionally capable of collecting, processing and/or
storing information about each grinding episode.
The present invention also provides a mouth piece, mouth guard or teeth
guard as described above coupled with a receiving device capable of
receiving the action signal from the mouth piece, mouth guard or teeth
guard and generating a cognizable bio-feed back output in response to each
grinding episode at either a conscious or subliminal level, i.e., if the
wearer is asleep, the output can either wake the wearer up or generate an
output that can be sensed by the brain without waking the wearer up, while
if the wearer is awake, the output such must be sufficient to cognizable
to the wearer.
The present invention further provides mouth piece, mouth guard or teeth
guard devices as described above coupled with a data acquisition device
capable of receiving the transmitted signal from the mouth piece, mouth
guard or teeth guard and either dynamically, periodically or upon user
demand analyze information contained in the signal or derived from the
signal, including the frequency and duration of each grinding episode and
optionally a pressure pattern and/or intensity pattern associated with
each grinding episode.
This invention further provides for mouth piece, mouth guard or teeth guard
devices as described above incorporating both a device capable of
rendering a bio-feed back response and a device capable of collecting and
storing of data contained in the transmitted signal from the mouth piece,
mouth guard or teeth guard device.
This invention also provides methods for augmenting teeth grinding habits
including placing in the mouth of a user a mouth piece, mouth guard or
teeth guard as described above, transmitting a signal produced in response
to a change in a state of the pressure sensors, receiving the signal from
the mouth piece, mouth guard or teeth guard and generating a user
cognizable response to each grinding episode sufficient to make the user
aware of the episode either consciously or subliminally.
This invention further provides methods for acquiring data regarding teeth
grinding habits including placing in the mouth of a user a mouth piece,
mouth guard or teeth guard as described above, transmitting a signal
produced in response to a change in a state of the pressure sensors,
receiving the signal from the mouth piece, mouth guard or teeth guard in a
data storage device and storing data contained in the signal in the device
corresponding to a set of properties of each grinding episode.
The previous two methods can also be combined to provide a method for data
acquisition and bio-feed back.
The present invention also provides methods for making mouth guards with
pressure sensors contained therein and associated electronics and methods
for making the bio-feed back and data acquisition systems utilizing the
mouth guards of the present invention.
This invention further provides a new membrane pressure sensing device and
methods for making and including the devices in mouth pieces.
Thus, one aspect of this invention is to provide apparatus designed to
diagnose and/or collect information about the human problems associated
with grinding of teeth during sleep. Another aspect is to use such devices
to treat the teeth grinding towards a cure. Another aspect of this
invention is to provide methods for manufacturing mouth guards comprising
plastic laminants having pressure sensors, radio transmitters and
associated electronics contained therein and methods for fitting such
devices to a human mouth.
The present invention further provides an mouth guard including an outer
layer conforming substantially to the shape of an upper teeth and pallet
outline of a person having a top substantially conforming to the upper
teeth and pallet or roof of the mouth of the person and a bottom which is
relatively smooth and designed to engage the teeth of a lower jaw. The
mouth guard further includes sensing layer contained within the outer
layer where the sensing layer includes a plurality of metal dome switches
distributed along a molar region of the mouth guard in electrical
communication with electronics located in the pallet region of the guard
and also contained within the outer layer of the guard. The switches are
design to be in an OFF condition (open circuit condition) when no force is
applied between the top and bottom of the outer layer of the guard and to
be in a ON condition (closed circuit condition) when a force sufficient to
overcome a force rating of each switch. The electronic includes a battery,
an integrated circuit and electric wires connecting the battery, IC and
switches. The IC includes a transmitter and the electric wiring includes
an antenna.
The present invention further provides an mouth guard including an outer
layer conforming substantially to the shape of an upper teeth and pallet
outline of a person having a top substantially conforming to the upper
teeth and pallet or roof of the mouth of the person and a bottom which is
relatively smooth and designed to engage the teeth of a lower jaw. The
mouth guard further includes sensing layer contained within the outer
layer where the sensing layer is a membrane switch including a top layer,
a middle layer and a bottom layer. The top layer includes a conductive
area and wires extending from the conductive area. The middle layer
includes a plurality of perforations arranged in regular or irregular
patterns. The bottom layer includes a conductive area and wires extending
from the conductive area where the bottom layer conductive area conforms
substantially to the top layer conductive area. The membrane switch is
design to be in an OFF condition (open circuit condition) when no force is
applied between the top and bottom of the outer layer of the guard and to
be in a ON condition (closed circuit condition) when a force sufficient to
overcome a force rating of switch. The electronic includes a battery, an
integrated circuit and electric wires connecting the battery, IC and
switches. The IC include a transmitter and the electric wiring includes an
antenna.
The present invention also includes a battery-less mouth guard where
everything save the battery can be any one of the embodiments described
above or any combination thereof and where the power needed to transmit a
signal is obtained from an energy field which microelectronic circuits,
preferably mounted in the pallet area of the device and antenna following
the front outer contour of the guard, capable of being energized or
extracting energy from the field. The energy is then used by the mouth
guard to transmit a signal whenever the sensing layer within the mouth
guard changes state indicating sufficient force being applied across the
sensing layer to change the state of the circuit (open to closed). The
change in state closes circuits in the electronic circuitry of the mouth
guard allowing the circuitry to be energized by the energy field resulting
in signal generation and transmission to a receiver. Of course, the wearer
must be within the active zone of the energy field for the battery-less
unit to work. Thus, the energy field generator should be located in a
bedroom of the wearer sufficiently close to the bed so that when the
circuitry in the guard closes due to a bruxing episode of sufficient force
to change the sensing device from an open state to a closed state, the
device will be able to extract energy from the field, generate and
transmit a signal evidencing the change in state of the pressure sensing
device within the guard.
DESCRIPTION OF THE DRAWINGS
The invention can be better understood with reference to the following
detailed description together with the appended illustrative drawings in
which like elements are numbered the same:
FIGS. 1a-c are a top schematic view, side view of a mouth guard and a top
view of a receiver unit of the present invention;
FIG. 2a is an electrical schematic of one embodiment of a transmitter;
FIG. 2b is an electrical schematic of one embodiment of a receiver/alarm;
FIG. 3 is another embodiment of a mouth guard of the present invention;
FIG. 4a is a cross-section view of a section of the membrane of FIG. 3 at
line segment 1-1';
FIG. 4b is a cross-section view of a section of the chip and battery
compartment of FIG. 3 at line segment 2-2';
FIG. 5a is a top view of the perforated film of the membrane of FIG. 3;
FIG. 5b is a top view of the bottom film and associated circuitry of the
membrane of FIG. 3;
FIG. 5c is a top view of the top film and associated circuitry of the
membrane of FIG. 3;
FIG. 6 is a schematic diagram of the pin arrangement of the chip associated
with the mouth guard of FIG. 3;
FIG. 7 is another embodiment of a mouth guard circuitry board designed to
accommodate a plurality of tactile metal dome switches;
FIGS. 8a-c is a first embodiment of a second type of membrane switch of
this invention;
FIGS. 9a-c is a second embodiment of a second type of membrane switch of
this invention;
FIGS. 10a-c is a third embodiment of a second type of membrane switch of
this invention;
FIG. 11 is a schematic block diagram of another embodiment of the receiver
unit of this invention;
FIG. 12 is a top view of a top of one preferred printed circuit board for
the receiver unit of FIG. 11;
FIG. 13 is a top view of a bottom of printed circuit board of FIG. 12;
FIG. 14 is a component schematic diagram for the placement of components on
the printed circuit board of FIG. 11;
FIG. 15 is an electrical schematic diagram of the receiver of FIG. 11;
FIG. 16 is an electrical schematic diagram of the time/counter of FIG. 12;
and
FIG. 17 is an electrical schematic diagram of the tone ramp of FIG. 12.
DETAILED DESCRIPTION OF THE INVENTION
The inventors have found that an apparatus can be constructed that
incorporates into a mouth guard or piece at least one pressure sensor in
electric communication with an electronic device capable of monitoring the
pressure sensor(s) and transmitting a signal when a state of one sensor or
a plurality of sensors changes in response to a teeth grinding episode.
Besides simply signifying whether the monitored state has changed, the
transmitted signal can optionally include data indicating which sensors
have changed state, the pressure amplitude experienced by each activated
sensor, and/or a direction perpendicular to an applied force.
The inventors have also found that the mouth piece containing pressure
sensors and a transmitter can be coupled with a receiver unit that is
capable of receiving the transmitted signal from the mouth piece or guard
and generating a human cognizable response such as a sound, vibration,
pressure contact, electrical stimulus, taste and/or smell stimulus other
cognizable sensory output or combinations thereof. The cognizable response
can cause a wearer or user to become conscious of the fact that he/she is
grinding his/her teeth or preferably, the response is designed to cause a
subliminal recognition of the onset of a grinding episode. The response is
designed to induce a behavioral recognition of the onset and cessation of
a grinding episode and potentially induce a behavioral modification of a
grinding habit to either reduce or eliminate this potential dental
damaging habit.
The inventors have also found that the transmitting mouth guard can also be
coupled to a data acquisition system capable of receiving the transmitted
signal and storing the information contained in the signal so that the
frequency of episodes and other properties of each grinding episode can be
stored for dynamic or subsequent analysis.
One embodiment of the present invention includes, an improved dental mouth
piece that helps protect the wearer's teeth against the harmful effects of
daytime or nighttime bruxing (forceful grinding and clinching of the
teeth) and helps minimize the frequency and intensity of the bruxing. In
addition to the standard, molded plastic dental nightguard that is custom
fit and slips snugly onto and covers the upper or lower teeth, this
improved guard contains electronics that give instant feedback by alerting
the wearer when he/she begins to brux. When the wearer begins to brux
these electronics consisting of a pressure activated switch, radio
frequency transmitter and battery power source sends a radio signal to a
wrist alarm which alerts the wearer. When the wearer stops bruxing, the
alarm stops automatically.
The mouth guard can be constructed of any plastic material, laminant
material or composite material. Such material include, without limitation,
polystyrene, elastomers such as polybutadiene, styrene-butadiene
copolymers, natural rubber, or the like, thermoplastic elastomers such as
SBS, SIS or similar thermoplastic elastomers, polyesters, polyacrylates
and/or acrylics, polyurethanes, polyamides, polyolefins, polylactones, or
the like or mixtures or combinations thereof. Suitable materials also
include any material currently used to make mouth pieces. These materials
can be used in either a cured or uncured state for those material that can
be chemically or radiation cured. Preferably, the materials used on the
exterior surfaces of the mouth pieces of the present invention are Food
and Drug Administration approved for use in the mouth. The mouth piece or
guard is preferably constructed of a flexurally resilient material so that
the mouth piece can undergo repeated grinding episodes without significant
loss of integrity or flexible fatigue.
The pressure sensors are generally incorporated into regions of the mouth
guard that become interposed between teeth in an upper jaw and lower jaw
of a wearer during a grinding episode. The sensors can be simple pressure
activated on/off switches such as membrane switches and/or devises such as
a load cell, strain gauge and/or polymeric membrane pressure gauges
(elastomer switches) which generate an output signal proportional to
either a magnitude and/or a magnitude and a direction of forces
experienced by the pressure sensor during a grinding episode.
The monitoring and transmitting device is generally a chip having
processing capabilities sufficient to monitor and determine a change in
pressure state of at least one pressure sensor and to transmit a signal
when a change in the state of one or more pressure sensors occurs. The
device can either transmit a continuous signal (persistent signal) until a
normal state is restored in the activated pressure sensors, transmit an
intermittent signal while a sensor is in an activated or non-normal state
or generate a start signal and a stop signal marking the start of a
grinding episode and the stop of the episode.
If the pressure sensors are capable of monitoring amplitude and/or
direction of applied forces, then the transmission is preferably
continuous, but interment signals with amplitude and/or directional
information averaged over duration of the interment signal or un-averaged
can also be used.
Besides using a transmitter located in the mouth piece and a separate unit
to generate an human cognizable output, the mouth piece itself can include
a electronic and mechanical unit that generates an output directly into
the wearer's mouth. Such units could include vibratory devices such as
peizoelectric transducers, other harmonic oscillating devices or other
devices that can vibrate. The vibrations can be direct upward to the
palate or downward to the tongue or to both the palate and the tongue.
The output unit could also be a device that administers a small the
cognizable electric stimulus or shock. Additionally, the unit could be
release a chemical agent that would either stimulate smell, taste or a
combination thereof. Moreover, the mouth piece devices of this invention
can include any combination of output devices both in the mouth piece and
external to the mouth piece.
Furthermore, the data collection, processing and storage hardware and
software could be all located in the mouth piece where the mouth piece can
be removed from the mouth and the collected data downloaded from the
device into an external data analysis unit.
One preferred embodiment of the night mouth guard of the present invention
broadly includes the following three basic components:
One embodiment of the battery-less guard utilizes a power oscillator which
produces ultra high frequency short wave energy from an associated
antenna. An antenna in the guard is tuned to receive this signal and
circuitry in the mouth guard is designed to extract energy from the energy
from the power oscillator when the sensing circuit is closed to generate
and transmit a signal evidencing a bruxing episode. Such systems power
oscillator and receiver circuits are more fully disclosed in U.S. Pat.
Nos. 4,288,689, 4,532,511 and 5,019,815, incorporated herein by reference.
Other embodiments of the battery-less guard utilize electric and magnetic
energy fields and antennas and circuitry in the mouth guard capable to
extracting energy from such fields and using that extracted energy to
generate and transmit a signal when the sensing device in the mouth guard
is activated (changes to a closed condition) during a bruxing episode.
Further information about these energy field generating systems and the
circuitry effective in extracting energy therefrom is disclosed in U.S.
Pat. Nos. 5,733,313, 5,140,263, 5,283,400 and 5,019,815, incorporated
herein by reference.
In all of these embodiments utilizing energy fields to supply the required
energy to the guard electronic when the sensing device is in a closed
circuit state, once a signal from the mouth guard is generated and
transmitted, a receiver capable of receiving the signal then generated a
bio-feed back response to the wearer and/or records and stores the
transmitted signal. The stored data can include start/stop information,
duration information, power information and other information contained in
the signal.
Section I
A plastic horseshoe shaped dental night mouth guard worn on the upper or
lower teeth, preferably the upper teeth. It is made of plastic custom
molded to the wearer's mouth and each individual tooth. Positioned inside
the molded nightguard and lying flush with the biting surface of one or
more teeth are one or more elastomer switches. (These elastomer switches
and the electrical wires running from them are covered with a layer of
flexible plastic and hermetically sealed therein such as those available
from Elastomer Technologies, Philadelphia, Pa.). The wires running from
the elastomer switches pass through a rear wall of the night mouth guard
and into a central region located in a palette region of a wearer's mouth
where electronics for monitoring the switches and transmitting a signal
corresponding to the state of the switches are located.
Section II
A molded plastic and hermetically sealed compartment located in the concave
space created by the horseshoe shape of the night mouth guard. This
compartment is molded to and firmly attached to the rear wall of the
horseshoe shaped night mouth guard. Inside this compartment is a cordless
radio transmitter and battery power source. When the wearer begins to
brux, the elastomer switch is depressed causing it to activate the
transmitter which sends a radio signal to a receiving unit.
Section III
A wrist alarm or any other receiving unit is designed to receive the signal
transmitted by the mouth device. The wrist alarm employs an audio and/or
vibration alarm option which alerts the wearer the moment bruxing begins.
(The elastomer switch is a toggle so the alarm activating signal is only
sent for as long as the switch is depressed by the bruxing pressure). The
moment the wearer stops bruxing, the signal stops and the alarm ends until
the next grinding episode.
How to Use
Prior to going to sleep the wearer will insert the Dental Nightguard with
Biofeedback into his/her mouth and slip it over the upper teeth where it
will remain for the night. The wearer will then strap on the wrist alarm
and turn the wrist alarm power switch to on. Upon waking at the end of the
night, the wearer will turn the wrist alarm power switch off and remove
the mouth guard from the mouth. Of course, the device of the present
invention can be worn during the day to act as a bio-feed back unit or as
a data acquisition system to study teeth grinding during work.
Although the mouth guard can incorporate any type of pressure sensor, the
inventors have found that a preferred sensor is a membrane having at least
one pressure sensing region or switch embedded between two mouth
compatible plastic or rubber sheets in at least on tooth socket or cavity
in the mouth guard.
Moreover, the electronic units and battery can be located in other regions
of the mouth piece than in the palate region of the mouth. The electronic
could be located in areas of the mouth piece that extend up onto the side
of the teeth and up onto the gum. Further more, any other power supply can
be used provided that the supply mechanism generates sufficient power for
night time or day time monitoring. The power supplies can also be
rechargeable.
Preparation of a Membrane Switch of This Invention
Prior art uses of polyamides including caprolactam polyamides such as
Kapton sold by the DuPont company under the trade name PYRALUX.RTM., have
been primarily for single and multi layered flexible circuitry in the
telecommunications industry for such devices as small, portable phones and
wirelines used in the oil industry. There are well established procedures
for using these polyamide materials to incorporate metal circuitry in a
polyamide laminant.
The inventors have found that these polyamide materials can be used to form
flexible pressure sensing switches or detectors. The pressure switches are
designed to be laminated between two acrylic sheets or similar plastic
materials so that the switch is in a normal open or off state until
pressure is applied to the laminant sufficient to cause the switches to
change to a closed or on state. The acrylic sheets generally have a
thickness between about 0.005 and about 0.10 inches, with thicknesses
between about 0.010 and about 0.08 being preferred and thicknesses between
about 0.020 and about 0.060 being particularly preferred.
The membrane switch of the present invention includes a perforated
insulating layer interposed between two sheets of polyamide material with
conductive circuitry on their sides that contact the perforated insulating
layer. The perforations are preferably patterned to coincide with
conductive mesh patterns associated with the conductive circuitry.
Although any conductive material can be used preferred conductive
materials include conductive metals such as the noble or group VIII
metals, the group 1b metals, including gold, silver, platinum, palladium,
iridium, rhodium, copper or the like. Besides metals, conductive polymers
can be used as well.
Material Requirements
The process for making the membrane switches of the present invention
utilizes the following materials: (a) two 12".times.12" sheets of
single-sided copper clad polyamide where the copper is of a thickness is
equal to about one once of copper per square foot of polyamide film. It
should be recognized that any sheet size can be used to make the membrane
switches of this invention as is well-known in the art. One preferred
copper clad film is sold by the DuPont company under the trade name
PYRALUX LF9110. The polyamide film is about 0.001 inches thick; (b) one
12".times.12" sheet of polyamide sandwiched between two adhesive layers.
The film thickness is about 0.001 inches and the adhesive layers are about
0.001 inches thick. One preferred adhesive polyamide sheet is sold by the
DuPont company under the trade name PYRALUX LF0111.
Tooling
The process is performed using the following tooling: All etched images and
corresponding perforated core membrane must have common mechanical
reference points outside the final useable area for registering the 3
different sheets when "booking-up" for pressing together in the lamination
process. Photoplotted Mylar.RTM. positives of computer aided design images
of a top circuit layer and bottom circuit layer must be made with
registration of all desired images, (number of individual units desired),
all stepped and repeated precisely. Registration targets for tooling pins
must have been added outside the usable area in the periphery of the film.
These targets must be common to all sheets of plotted films and the "XY"
coordinate list that will be used to drill or punch the same locations in
the periphery of the actual film sheets to be used in manufacturing. A
"drill file" or ascii readable list of the tooling targets is saved for
use in the manufacturer's machining department.
Processing
The process includes preparing as follows: (a) lay the two sheets of copper
clad polyamide film or sheet material with the copper surface directed
toward each other with the adhesively coated polyamide sheet interposed
there between. These three films or sheets are then sandwiched between two
sheets of "backup-material, " which is generally a hard material such as
pressed board or Masonite with smooth, flat coplanar top and bottom
surfaces as is well-known in the art. The construct is then pinned
together to form a "book" that can then be held in place on a precision
drilling machine commonly referred to as a computerized numerically
controlled (CNC) drilling machine as is well-known in the art.
The machine is then loaded with coordinates that correspond to the common
reference targets (tooling holes). The drilling operation is conducted at
a feed and speed rate the will cut and remove portions of the films or
sheets of polymeric material without tearing or smearing the materials.
The target holes have a diameter that corresponds to common pin diameters
including without limitation pin sized of 0.125, 0.156, 0.187 or 0.250
inches or combination thereof.
After the tooling holes are drilled, the book is taken apart and the two
metal clad films or sheets are set aside. Using common tooling practices,
the CNC machine is loaded with the information needed to drill holes in
the interposed insulator sheet or film to form the perforated interposed,
insulator sheet or film. The interposed film is then remounted on the CNC
machine sandwiched between two slip sheets generally made of Teflon. An
entry material such as a metal plate or film is then placed on top of the
sandwich interposed layer such as an aluminum "entry" material. Holes are
then drilled in the mounted interposed, insulator sheet placing holes or
perforations in a desired pattern derived from the CAD design of the final
membrane switch which contains the information for constructing the
membrane switch from its constituent parts. Once the perforations or holes
have been drilled in the interposed, insulator sheet, the sheet is removed
from the machine or breakdown of the book occurs and the sheet is set
aside.
Printing Circuits
With the perforated film prepared, the printed circuits on each metal clad
film is constructed. The process of forming the circuitry on the metal
clad circuit sheets generally includes first cleaning the metal surface as
is well-known the art in preparation for applying a photo-resist. The
photo-resist can be any photo-resist used in the art, provided that the
photo-resist is compatible with the metal making up the cladding such as
photo-resistive inks or laminated films. One preferred laminated film is
the Riston 200 series of dry films from the DuPont company. In addition,
any other technique for forming circuitry on the surface of polymeric
materials form can be used as well as other type of polymers as is well
known in the art.
The photo-resist in then applied to the cleaned metal surface. A
photoplotted film or mask which have transparent and opaque areas
corresponding either to a positive or a negative image of the desired
circuitry is then aligned with the registration targets and tooling holes
that are drilled on the material. The masked, photo-resist coated metal
clad sheet is then exposed to a high intensity UV light using a so called
contact camera for a duration prescribed for the particular photo-resist
being used to form a photo-cured pre-circuit sheet. The UV light cures the
photo-resist exposed to the light, leaving the unexposed photo-resist
uncured. The photo-cured film is then developed to remove uncured or
unexposed photo-resist leaving the corresponding metal surface
unprotected. In the preferred process, the portions of the metal surface
having the cured photo-resist thereon will become the circuitry and the
unprotected or exposed portion of the metal surface will be removed.
Once the uncured photo-resist has been removed and the corresponding metal
surface exposed, the developed sheet is optionally visually inspected to
ensure the integrity of the cured photo-resist. The sheet is then
subjected to an etching process that will remove the exposed portions of
the metal surface. Any etching process known in the art could be used in
the practice of this invention. Such etching processes include a dip or
spray etch commonly referred to as the "Peroxy-Sulfuric" process or the
"Alkaline Ammoniacal" spray etch. Either process is acceptable with proper
neutralization and rinsing after etching; however, one of ordinary skill
would recognize the polyamides can degrade in the presence of highly
alkaline solutions which can cause a swelling of the material, if the
material is not properly cleaned afterwards.
After etching, the circuit sheets are cleaned and rinsed thoroughly. The
clean sheets are then dried, preferably in a convection oven at a
temperature preferably not exceeding about 200.degree. F. for a time not
to exceed about 30 minutes. However, other temperatures and times can be
used provided that the film is not damaged or degraded by the thermal
history (temperature and time). After drying, the material is allowed to
stress relieve for a period of about 3 hours at room temperature in a
clean, low humidity area. The period of stress relief is not critical, but
should be sufficient to allow the film and metal thereon to come to a new
equilibrium state. Of course, the top and bottom sheet circuitry is not
the same so each sheet will have its own photomask associated therewith
producing the circuitry intended for that sheet.
Lamination
When making small quantities of the membrane switches of this invention,
windows or areas that are to be removed from the top metal clad sheet and
from the perforated sheet to expose the portions of the circuitry of the
bottom layer or sheet can be removed by any method known in the art
including, without limitation, cutting away the windows or areas by hand
using an X-Acto knife or other surgically clean and sharp instrument. The
"membrane" layer (perforated sheet) is cut away approximately 0.075 inches
higher than the top circuitry containing layer. This is to expose one of
the circuits of the Top to overlay and touch one of the circuits on the
Bottom that corresponds to it on the design. These circuits are,
eventually during the final assembly process, joined by a small bead of
Tin-Lead solder to give continuity to this essential circuit. When making
larger quantities of the membrane switches of this invention, the window
cutting step is generally performed with a steel-ruled die for more
accurate and quick removal.
Using pins corresponding in diameter to the tooling holes previously
drilled in the materials, lay in order first the bottom circuit layer,
copper circuits side up, next, the middle membrane material with any and
all protective sheeting applied during raw manufacturing removed, and
finally the top circuit layer, copper circuits side down. With the
materials firmly held by the pins in registration, the pre-laminant is
tacked down in several places along its edge to hold it together with a
hot soldering pencil or other tacking device. Hold the pencil down against
the material in each tack spot for a duration of approximately 10 seconds
at a temperature of about 500.degree. F. Tacking melts the adhesive on the
top and bottom of the middle or perforated membrane layer and bonds the 3
pieces, (sheets of material) so they cannot become mis-registered in the
final process to form a pre-laminated membrane switch sheet.
Using a common art "Laminating Press" (such as ones used normally for
making multilayered printed circuit boards), the laminating process
generally uses "press plates", "separator plates", and Teflon release
sheets such as "Tedlar" or "Pacothane." Book up the press fixture in the
following order: (a) a 0.250 inch bottom press plate preferably steel; (b)
a bottom press pad or driving medium such as "Kraft" paper in multiple
sheets or thermally resistive rubber sheet or specifically manufactured
materials for this use such as "PacoPad" or "Isolam;" (c) a bottom
stainless steel separator plate with IPC approved smoothness, polish, and
co-planarity; (d) a teflon release sheet;"(e) the pre-laminated membrane
switch sheet; (f) a teflon release sheet; (g) a top stainless steel
separator plate; (h) a top press pad similar to the bottom press pad (b);
and (i) a 0.250 inch top press plate similar to the bottom press plate
(a).
It should be recognized that this method of booking is a departure from the
norm of prior art. Usually, the press pads (driving medium) are used
between every (c) and (d), and (f) and (g). This is to make the soft
adhesive and plastic cores of the top and bottom layers of flexible
circuits conform to and around any copper areas thereby sealing them more
completely. This would not be a desirable effect in the membrane switch of
this invention, because there are purposeful gaps created for the eventual
pressing together (when the units are functioning as a switch) of the top
and bottom copper circuits.
Using the normal 0.187 inch press pins that are used in printed circuit
lamination, pin the entire book together in the middle of all four sides.
Prior art uses this system and all constituents of the book are normally
machined to register together this way. Place the book in a "Laminating
Press" that has been preheated to about 360.degree. F. and immediately
apply a pressure about 250 psig. Since most Laminating Presses measure
pressure in tons; for a 12 inch by 12 inch panel of membrane switches of
this invention, the pressure corresponds to 18 tons.
When the book comes to full heat in the area of the membrane switches, it
should stay under continual pressure for about 90 minutes. A set heat
timer or program should shut off heating and maintain the laminate under
pressure until the membrane switches or laminate cool down to a nominal
125.degree. F.
After the press opens, take the book apart and remove panels of the
laminated membrane includes a plurality of switch regions. Allow the
laminated membrane to stress relieve for about 12 hours at room
temperature while lying flat before any further use is made of the
membrane such as assembly into a mouth piece. Of course, again, the time
and temperature utilized for stress relief of the membrane can be other
than 12 hours at room temperature provided that the temperature history
does not adversely affect the membrane switch of this invention.
Although a preferred method for making the membrane switches of the present
invention has been described above, any other method known in that art can
also be used provided that the membrane switch can be activated by the
pressures normally experienced in a grinding episode. Regardless of the
type of pressure sensor used, the activation pressure for on/off type
switch is preferably not set so low that incidental clinching of the teeth
will not cause the pressure sensor to turn on. Preferably, the on pressure
is between about 1 and about 50 psi, particularly between about 5 and
about 50 psi and especially between about 10 and 50 psi. However, lower or
high on pressures can be used and for mouth pieces for small children the
ranges may be lower. For sensors that produce signal proportional to the
magnitude of the applied force regardless of the magnitude of the force,
the electronic preferably is designed with a pressure threshold signal
intensity below which no transmitted signal is generated and above which a
transmitted signal is generated.
Additionally, the electronics can contain monitoring logic such that a
signal is not generated until a transmit state is reached. Although the
transmit state can be activated simply whenever a pressure on/off type
switch is activated or a pressure threshold signal intensity occurs, more
sophisticated logic can be included so that the transmit state is not
activated until a given pressure conditions persists for more than a set
time or until a set pressure amplitude is achieved. Of course, the
electronics include logic to determine when to stop the transmitted signal
as well. Thus, the transmitted signal would stop or a stop signal would be
generated when the on pressure state changes to the off pressure state,
i.e., the activated on/off switches turn off or the continuous pressure
sensor signal drops below the pressure threshold intensity.
Referring now to FIG. 1a-c, a first embodiment of a mouth guard device of
the present invention (shown to include a mouth guard and a writ alarm
unit) can be seen to include a molded plastic mouth guard 12 as described
in Section I above. This guard 12 is custom made to contours of a
prospective wearer's teeth by molding a piece of plastic to a plaster mold
of an upper teeth of the wearer. Pockets or sockets 14 are formed in the
guard 12 to snugly fit around sides and biting surfaces of each individual
tooth so the guard 12 will be comfortable and won't fall off the teeth.
When inserted into the wearer's mouth, the guard 12 provides a protective
layer of plastic between the upper and lower teeth.
Pressure activated elastomer switches 16 are embedded laterally in the
molded plastic guard 12 flush with a biting surface of one or more teeth.
These switches 16 are covered and hermetically sealed with a layer of
flexible plastic 18. Also covered and sealed in the plastic 18 within the
guard 12 are electrical wires 20 running from the switches 16 through a
rear plastic wall 22 of the guard 12 into Section II 24, the molded
plastic electronics compartment.
The compartment 24 includes a coin shape battery power source 26 and an
optional holder (not shown) and a radio frequency transmitter 30. Section
II or the plastic compartment 24 is molded to the plastic guard 12
(Section I) embedding the battery 26 and transmitter 30. When the wearer
bites down on the guard 12, pressure is applied to the elastomer switches
16. This pressure causes the conductive particles contained in the
elastomer switches 16 to conduct. This activates the transmitter 30 which
sends a radio signal to activate an alarm 32 contained in a receiver unit
34. The compartment 24 also includes a radio antenna 36 associated with
the transmitter 30 for proper signal projection.
The combined device of FIGS. 1a-c also includes a receiving unit 34 which
is shown in the figure as a wristband 38. The wristband 38 includes a
power on/off switch 40 and the alarm 32. One embodiment of an electrical
schematic of a monitoring and transmitting circuit generally 42 is shown
in FIG. 2a; while FIG. 2b shows one embodiment of an electrical schematic
for a receiver/alarm circuit generally 44.
Referring now to FIG. 3, a second embodiment of a mouth guard of the
present invention is shown generally 50, including a mouth piece 52 which
fashioned to conform to a user's upper jaw and teeth. The mouth piece 52
includes a pressure sensitive membrane 54, a chip/transmitter 56 and a
battery 58 for supplying power to the membrane 54 and the chip 56 which
are in electric communication all encapsulated in a biocompatible plastic
material 60 as shown in FIGS. 4a-b which are cross-sectional segment
views. The preferred chip or microprocessor for use in this application is
a PCM-170 chip available from RFM of Dallas, Tex. The preferred plastic
material is a clear acrylic polymer such as so-called dental grade
acrylic.
The pressure membrane 54 includes a plurality of pressure switches 62. The
switches 62 can all be in electrical communication with each other so that
activation of any switch results is a change in state of the membrane as
shown in FIGS. 5a-c or each switch can have its own individual circuit so
that the device can determine which switch has been activated. As shown in
FIG. 6, the chip or integrated circuit 56 includes a transmitter (not
shown) and a plurality of pins 66a-f that are connected to a matching
plurality of circuit elements ends 68a-f associated with circuit elements
70a-f of the membrane 54, as shown in FIGS. 5a-c and 6. (Note elements 70b
and 70c do not exist in the embodiment and would be used on chip based
data acquisition, data analysis and processing and storage).
The pressure switches 62 are on/off type switches that are normally in an
open or "off" state changing to a closed or "on" state when sufficient
pressure is applied across the membrane 54 so that at least one switch 62
changes to its closed or "on" state causing the entire membrane 54 to be
in its closed or "on" state. Obviously, if each switch has its own
circuit, then the microprocessor/transmitter 56 will be able to determine
which switches have been activated, data that could be used to analysis
pressure patterns during bruxing episodes. The pin 66a is connected to
element 70a at element end 68a which corresponds to one side of the
membrane switch circuit. The pin 66f is connected to element 70f at
element end 68f which corresponds to the other side of the membrane switch
circuit and is also connected to a positive terminal 72 of the battery 58.
The pins 66b,c and e are connected to ground or a negative terminal 74 of
the battery 58. The pin 66d is associated with an antenna 76 for the
transmitter 56.
Thus, when the membrane switch closes due to pressure exerted on the
membrane during a grinding episode, power flows to the transmitter 56
which generates a signal indicating a change of state of the pressure
membrane 54 or an individual switch 62. Of course, the pressure switches
62 can also be load cells or elastomer membranes instead of simple on/off
switches contained in the pressure membrane 54. If load cells, elastomer
membranes, strain gauges or other pressure sensors are used, the device 50
can be used not only to measure the frequency and duration of grinding
episodes (signal on, signal off and the period of time between signal on
and signal off), but also the amplitude and/or direction of the pressure
experienced by the sensors during each grinding episode.
Looking now in more detail at FIGS. 3 and 5a-c, the membrane 54 is a
composite structure including a first copper clad sheet 78 having a first
circuitry 80 associated therewith, which circuitry 80 includes a plurality
of electrically connected wire mesh regions 82. The membrane 54 also
includes a middle, insulator sheet 84 having perforations 86 therethrough
and adhesive layers (not shown) associated with its top surface 88 and
bottom surface 90. The membrane 54 also includes a second copper clad
sheet 92 having a second circuitry 94 associated therewith, which second
circuitry 94 includes a plurality of electrically connected wire mesh
regions 96 corresponding to the regions 82 of the first copper circuit
layout 80. The sheets 78, 84 and 92 are preferably composed of a polyamide
such as nylon and particularly of a polycaprolactam polymer made by DuPont
sold under the trade name PYRALUX.RTM.. Of course, any polymeric material
can be used provided it can be sealed into a usable membrane pressure
sensitive device.
Although the perforations 86 can be associated with the entire middle sheet
84, the perforations 86 are preferentially located in patterned arrays 98
corresponding to the meshes 82 and 96. The meshes 82 and 96 are
preferentially composed of thin copper lines 100 inscribed, printed or
etched (or by another suitable technique) diagonally within a containing
square or rectangular perimeter 102. The diagonal lines 100 associated
with meshes 82 and 96 can be physically manifested in the same direction,
but are preferentially, and as shown in the figures, physically manifested
diagonally opposed so that the resulting pattern of the composite membrane
is a grid pattern and preferably a perpendicular or square grind pattern.
The copper lines with the perforations interposed therebetween form the
basis for the pressure switches of the pressure sensitive membrane of the
present invention. Thus, when pressure is applied to the membrane in a
mesh region, the pressure brings the copper lines into electrical contact
through one or more perforations closing the switch circuit or membrane
circuit. Once the circuit is closed, the integrated circuit,
microprocessor or chip senses the change in state and activates the
transmitter which transmits a signal while the circuit is closed. When
pressure ceases, the circuit re-opens which is sensed by the chip and the
transmitter is deactivated and the signal stops.
Referring now to FIG. 7, another embodiment of a mouth guard circuitry
board generally 200 of this invention is shown which is designed to
accommodate a plurality of in tactile metal dome switches 202. The dome
switches can all have the same pressure rating (the amount of pressure
that must be applied to the switch to cause the dome to defect down and
close the circuit) or each switch can have a different rating or any other
combination of ratings. The circuit board 200 is in the general shape of a
wearer's teeth outline 204 and includes a plurality of interconnected
switch positive circuit elements 206 and interconnected negative circuit
elements 208. The circuit board 200 also includes an antenna 210 which
follows an outer contour 212 of the board 200 and a pallet region 214
having six sites 216 which are designed to come into electric contact pins
of a six pin IC and a positive battery terminal node 218 and negative
battery terminal node 220. Each pair of positive and negative circuit
elements is designed to receive a single dome switch. Thus, the board 200
of FIG. 7 is designed to accommodate 8 dome switches. When pressure is
applied across a given dome switch mounted on a give pair of elements,
then the metal dome of the switch will close the open circuit across the
given pair of elements activating the IC and causing a signal to be sent
to a receiver for processing. Of course, this board is designed to be
encased in a polymeric cover to electrically isolate the board and board
components from the fluids in the wearer's mouth.
The next three figures relate to a second type of membrane switch than the
membrane switch described previously. The membrane switches broadly
include a top layer, a bottom layer and a middle layer interposed
therebetween. The top layer can be either one element of the open switch
circuit or a shunt element. The middle layer is a sheet having a specified
density of perforation therethrough, where the perforations have a size
(diameter) and a preferably arrayed in a column-row arrangement. The
bottom layer includes the majority of the circuit elements for connecting
a battery and an IC to the circuit elements so that when a given pressure
is exerted across the membrane, the membrane is changed from an
open-circuit to a closed circuit which activates the IC causing the
antenna to transmit a signal.
Referring now to FIGS. 8a-c, a first embodiment of a second type of
membrane switch generally 250 of this invention is shown. The membrane
switch 250 includes a top layer 252, a middle layer 254 and a bottom layer
256. The top layer 252 is in the general shape of a wearer's teeth outline
258 and includes two rectangular shaped, positive circuit elements 260,
each element 260 having a wire 262 extending from its forward end 264 and
terminating at a pallet position 266. The middle layer 256 has
substantially the same general shape as the top layer and is designed to
be overlaid by the top layer 252. The middle layer 254 includes two
rectangular shaped, perforated members 268 positioned to correspond to the
positive circuit elements 260 after overlay. The bottom layer 258 has a
tooth region 270 and a pallet region 272. The pallet region 272 includes
six IC nodes 274a-f numbered 1-6 and a positive battery terminal node 276
and a negative battery terminal node 278. The pallet region 272 also
includes a positive wire element 280 extending from the positive battery
node 276 and terminating in two ends 282 one end connected to IC node 6,
274f. The tooth region 270 includes two rectangular shaped, negative
circuit elements 284 and a wire 286 interconnecting the elements 284 and
connecting the elements to IC node 1, 274a and following an outer contour
288 of the pallet region 272. The bottom layer 258 also includes an
antenna 290 extends from the pallet region 272 and follows a forward outer
contour 292 of the tooth region 270. When pressure is applied across the
membrane sufficient to bring one or both of the positive elements in
contact with the negative elements, then the switch will close activating
the IC and causing a signal to be sent to a receiver for processing. Of
course, this board is designed to be encased in a polymeric cover to
electrically isolate the board and board components from the fluids in the
wearer's mouth. The perforated sheets useful in the second-type of
membrane switches of the present invention are available from C&K
Components, Inc. of Watertown, Mass. These perforated sheets used as the
middle layer can be produced or manufactured with different threshold
pressure rating by controlling both the number and diameter of the
perforations in the sheet. Thus, activation pressures between about 5 and
20 psi can be constructed with dot diameters between about 0.1 mm and
about 1 mm and dot pitches (number of dots per cm.sup.2) between about 0.1
mm and about 5.0 mm distance between dots on a regular grid, i.e., 5.0
represents the least dots per cm.sup.2 and 0.1 represents the most dots
per cm.sup.2. The preferred sheets have pressure activations between about
8 and about 15 psi based on a preferred pitch between about 2.0 and about
0.5 and a dot diameter between about 0.2 mm and about 0.5 mm.
Referring now to FIGS. 9a-c, a second embodiment of a second type of
membrane switch generally 300 of this invention is shown. The membrane
switch 300 includes a top layer 302, a middle layer 304 and a bottom layer
306. The top layer 302 is in the general shape of a wearer's teeth outline
308 and includes two rectangular shaped, positive circuit elements 310,
each element 310 having a wire 312 extending from its forward end 314 and
terminating at a pallet position 316. The middle layer 304 has
substantially the same general shape as the top layer and is designed to
be overlaid by the top layer 302. The middle layer 304 includes two
rectangular shaped, perforated members 318 positioned to correspond to the
positive circuit elements 310 after overlay. The bottom layer 306 has a
tooth region 320 and a pallet region 322. The pallet region 322 includes
six IC nodes 324a-f numbered 1-6 and a positive battery terminal node 326
and a negative battery terminal node 328. The pallet region 322 also
includes a positive wire element 330 extending from the positive battery
node 326 and electrically connected to IC node 6, 324f and terminating in
an end 332. The tooth region 320 includes two rectangular shaped, negative
circuit elements 334 and a wire 336 interconnecting the negative elements
334 and connecting the elements to IC node 1, 324a and following an outer
contour 338 of the pallet region 322. The bottom layer 308 also includes
an antenna 340 extends from the pallet region 322 and follows a forward
outer contour 342 of the tooth region 320. When pressure is applied across
the membrane sufficient to bring one or both of the positive elements in
contact with the negative elements, then the switch will close activating
the IC and causing a signal to be sent to a receiver for processing. Of
course, this board is designed to be encased in a polymeric cover to
electrically isolate the board and board components from the fluids in the
wearer's mouth.
Referring now to FIGS. 10a-c, a third embodiment of a second type of
membrane switch generally 350 of this invention is shown. The membrane
switch 350 includes a top layer 352, a middle layer 354 and a bottom layer
356. The top layer 352 is in the general shape of a wearer's teeth outline
358 and includes two rectangular shaped, shunt elements 360. The middle
layer 354 has substantially the same general shape as the top layer and is
designed to be overlaid by the top layer 352. The middle layer 354
includes two rectangular shaped, perforated members 362 positioned to
correspond to the shunts 360 after overlay. The bottom layer 356 has a
tooth region 364 and a pallet region 366. The pallet region 366 includes
six IC nodes 368a-f numbered 1-6 and a positive battery terminal node 370
and a negative battery terminal node 372. The tooth region 364 includes
two rectangular shaped areas 374 comprising an interpenetrating network
375 of positive wires 376 and negative wires 378. The positive wires 376
are connected to a positive lead wire 380 which makes electrical contact
with IC node 6, 368f and the positive battery terminal node 370. The
negative wires 378 are connected to a negative lead wire 382 which makes
electrical contact with IC node 1, 368a and follows an outer contour 384
of the pallet region 366. The bottom layer 356 also includes an antenna
386 extends from the pallet region 366 following a forward outer contour
388 of the tooth region 370. When pressure is applied across the membrane
sufficient to bring the shunt element in contact with a positive and
negative wire of the interpenetrating wire networks, then the switch will
close activating the IC and causing a signal to be sent to a receiver for
processing. Of course, this board is designed to be encased in a polymeric
cover to electrically isolate the board and board components from the
fluids in the wearer's mouth.
Of course, in any of the embodiments of the second-type of membrane switch,
the positive and negative elements can be reversed without affecting the
operation of the guard. Additionally, the circuit elements and IC used can
be any circuit elements or IC that allow the pressure switch to activate
the control circuitry in the IC causing the IC to transmit a signal from
the antenna to a receiver which will then receive and act on the signal.
Morever, the battery included in each of the guard embodiments of the
present invention can be replaced by a thickened antenna which acts as the
negative terminal of the battery and is designed to extract electric
energy from a field bathing the guard when the open circuit of a pressure
switch in the mouth is closed. The field will then cause a current to flow
through the device activating the IC and causing the IC to transmit a
signal which is received and acted upon by the receiver.
Referring now to FIG. 11, the receiver/data acquisition/bio-feed back unit
150 of this invention broadly includes the following component: an RF
receiver 152, an event detector 154, a bio-feed back unit 156 capable of
generating an human cognizable response, and optionally a data acquisition
system 158. The data acquisition system 158 can include an event counter
160, an event display 162, an elapsed time/timing circuit 164, an elapsed
time display 166, a data storage device 168 and a data output unit 170.
The bio-feed back unit 156 can include an audible tone generator 172, a
tone ramp circuit 174 and a speaker 176. Of course, any other type of
bio-feed back unit can be used such as a vibrator or other pressure
inducing unit. The bio-feed back unit could also be an ear piece having a
receiver, an event detector, a tone generator, a tone ramp circuit and a
speaker. It should be understood that the bio-feed back unit can be any
unit capable of generating an human cognizable response, conscious or
subliminal.
EXAMPLES
The following examples are include for the sake of completeness of
disclosure and to illustrate the methods of making the compositions and
composites of the present invention as well as to present certain
characteristics of the compositions, but in no way are these examples
included for the sake of limiting the scope or teaching of this
disclosure.
Example 1
This example illustrates the construction of a receiver/data
acquisition/bio-feed back unit to be used in conjunction with the mouth
guards of the present invention. Although this constructed unit is capable
of receiving the transmitted signal from the mouth piece and in response
store the data for later analysis and generating an human cognizable
response, this unit is by no means intended to be limiting and it should
be recognized that any receiver, data acquisition and bio-feed back
apparatus can be used as well.
The unit 150 can include composed of a printed circuit board 178 having a
circuit layout 180 as shown in FIGS. 12, 13, and 14 where the circuit
layout is designed to implement schematic diagrams shown in FIGS. 15-13.
The board 178 includes the following list of components and corresponding
reference numbers for proper placement of the components on the printed
board 178 according to the layout 180 shown in FIG. 10:
______________________________________
Component/ Ref. Component/ Ref.
Element # No. Element # No.
______________________________________
capacitor 0.01.mu.F
C1 capacitor 1.mu.F
C2
capacitor 0.1.mu.F
C3 capacitor 330.mu.F
C4
capacitor 0.01.mu.F
C5 capacitor 1.mu.F
C6
capacitor 0.1.mu.F
C7 capacitor 0.01.mu.F
C8
capacitor 2.2.mu.F
C9 capacitor 0.33.mu.F
C10
capacitor 0.1.mu.F
C11 capacitor 47pF C12
capacitor 20.mu.F
C13 capacitor 0.1.mu.F
C14
capacitor 0.1.mu.F
C15 capacitor 0.1.mu.F
C16
capacitor 0.01.mu.F
C27 capacitor 0.01.mu.F
C28
capacitor 0.01.mu.F
C29 capacitor 220.mu.F
C30
capacitor 0.1.mu.F
C31 capacitor 0.1.mu.F
C32
capacitor 0.1.mu.F
C33 capacitor 0.01.mu.F
C34
capacitor 0.01.mu.F
C35 capacitor 0.01.mu.F
C36
capacitor 0.01.mu.F
C37 capacitor 0.1.mu.F
C38
LED display DS1 LED display DS1
LED display DS2 connector 10F J1
connector 10F J2 connector 10F J3
connector 10F J4 pot 3t 20K R1
resistor 4.7K.OMEGA.
R2 resistor 2.2K.OMEGA.
R3
resistor 10K.OMEGA.
R4 resistor 10K.OMEGA.
R5
pot 3t 10K.OMEGA.
R6 pot 3t 10K.OMEGA.
R7
resistor 4.7K.OMEGA.
R8 resistor 4.7K.OMEGA.
R9
resistor 100K.OMEGA.
R10 resistor 22M.OMEGA.
R11
resistor 10K.OMEGA.
R12 resistor 220K.OMEGA.
R13
resistor 14 dip 10K.OMEGA.
R14 resistor 14 dip 10K.OMEGA.
R15
resistor 10K.OMEGA.
R16 resistor 14 dip 10K.OMEGA.
R17
resistor 10.OMEGA.
R18 resistor 10K.OMEGA.
R19
resistor 10K.OMEGA.
R20 resistor 10 sip val
R23
pot 3t 10K.OMEGA.
R24 resistor 10K.OMEGA.
R30
resistor (used if
R32 7 pin dip switch
S1
different voltage)
7 pin dip switch
S2 test point TP1
test point TP2 test point TP3
dip14 LM339NA U2 dip 14 4066 U4
dip 8 LM555CNB
U5 RX1300 U6
dip 16 74HC4060
U7 dip 16 74HC4040 U8
dip 16 74HC190
U9 dip 16 4511 U10
dip 16 74123 U11 dip 16 74HC190 U12
dip 16 4511 U13 dip 16 74HC190 U14
dip 16 4511 U15 dip 14 74HC08 U16
dip 8 LM386 U17 dip 14 4066B U18
dip 14 4066B U19 dip 14 74HC164 U20
dip 16 74HC160
U21 dip 16 4511 U22
dip 16 74HC190
U23 dip 16 4511 U24
dip 16 74HC190
U25 dip 16 4511 U26
dip 16 74HC160
U28 dip 16 74HC42 U29
dip 14 74HC04 U30 TO-220AB LM7805CTB +
VR1
5V reg
TO-39 LM78L15ACZA +
VR2 XTAL crystal 32768
X1
15V reg
______________________________________
Of course, any other receiver unit can be used as well and any other
circuit board design can be used as well provided that the receiver can
receive a transmitted signal and generate a human cognizable response and
optionally store, analyze and/or output information about each grinding
episode such as duration, pressure amplitude and/or direction, time of
occurrence, or the like.
Although the invention has been disclosed with reference to its preferred
embodiments, from reading this description those of skill in the art may
appreciate changes and modification that may be made which do not depart
from the scope and spirit of the invention as described above and claimed
hereafter.
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